NDC 58331-301 Croc Bloc Spf 30 Fps Ecran Solaire

Octinoxate, Octisalate, Oxybenzone, Avobenzone, Octocrylene Liquid Spray Sunscreen

NDC Product Code 58331-301

NDC CODE: 58331-301

Proprietary Name: Croc Bloc Spf 30 Fps Ecran Solaire What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Octinoxate, Octisalate, Oxybenzone, Avobenzone, Octocrylene Liquid Spray Sunscreen What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 58331 - Degil Safety Products (1989) Inc.
    • 58331-301 - Croc Bloc Spf 30 Fps Ecran Solaire

NDC 58331-301-01

Package Description: 180 g in 1 BOTTLE, SPRAY

NDC Product Information

Croc Bloc Spf 30 Fps Ecran Solaire with NDC 58331-301 is a a human over the counter drug product labeled by Degil Safety Products (1989) Inc.. The generic name of Croc Bloc Spf 30 Fps Ecran Solaire is octinoxate, octisalate, oxybenzone, avobenzone, octocrylene liquid spray sunscreen. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Degil Safety Products (1989) Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Croc Bloc Spf 30 Fps Ecran Solaire Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OCTISALATE 4 g/100g
  • AVOBENZONE 2 g/100g
  • OCTINOXATE 7.5 g/100g
  • OXYBENZONE 4 g/100g
  • OCTOCRYLENE 1.5 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
  • POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)
  • WATER (UNII: 059QF0KO0R)
  • ISODODECANE (UNII: A8289P68Y2)
  • CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Degil Safety Products (1989) Inc.
Labeler Code: 58331
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-28-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Croc Bloc Spf 30 Fps Ecran Solaire Product Label Images

Croc Bloc Spf 30 Fps Ecran Solaire Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

May stain or damage some fabrics or surfaces.

Otc - Active Ingredient

Octinoxate7.5% w/wSunscreenOctisalate4.0% w/wSunscreenOxybenzone4.0% w/wSunscreenAvobenzone2.0% w/wSunscreenOctocylene1.5% w/wSunscreen

Otc - Purpose

Active IngredientsPurposesOctinoxate7.5% w/wSunscreenOctisalate4.0% w/wSunscreenOxybenzone4.0% w/wSunscreenAvobenzone2.0% w/wSunscreenOctocylene1.5% w/wSunscreen

Warnings

For external use only

Otc - Do Not Use

On damaged or broken skin

Otc - Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Otc - When Using

Avoid contact with eyes. Rinse with water to remove.

Otc - Stop Use

Rash and irritation develops and lasts

Directions

Apply liberally and evenly to dry skin 15 minutes belofe going Into the sun. Reapply at least fN8ry 2 houlS. Reapply after 80 minutes of swimming or sweating. Reapply lmmetlatety after towel drying.

• For children under 6 months of age: Ask a doctor

Other Information

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures inciucling: limit time In the sun, especially from 10 a.m.-2 p.m.; and Wear long-sleeved shirts, pants, hats, and sunglasses. lf used as directed with

other sun protection measures (See Dlrections), decreases the risk of skin cancer and early skin aging caused by the sun. Protect container from freezing.

Inactive Ingredient

Aqua, Aloe Barbadensis Leaf Exlract, lsododecane, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Methyl Glucose Sesquistearate, PEG-20 Methyl Glucose Sesquistearate, Polyester-8. PVP/Hexadecene Copolymer, Tocopheryl Acetate, Decyl Glucoside. Stearyl Alcohol, Ceteareth-20, Microcrystalline Cellulose, Cellulose Gum, Propylene Glycol, Disodium EDTA, Triethanolamine, Diazolidinyl Urea, Methylparaben, Propylparaben.

* Please review the disclaimer below.